Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age

Timo Vesikari; Sven Arne Silfverdal; Florence Boisnard; Stéphane Thomas; Grace Mwawasi; Donna Reynolds

doi:10.1128/CVI.00414-13

Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age

Clin Vaccine Immunol. 2013 Oct;20(10):1647-53. doi: 10.1128/CVI.00414-13. Epub 2013 Aug 21.

Authors

Timo Vesikari¹, Sven Arne Silfverdal, Florence Boisnard, Stéphane Thomas, Grace Mwawasi, Donna Reynolds

Affiliation

¹ University of Tampere Medical School, Vaccine Research Centre, Tampere, Finland.

Abstract

This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP(5)-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.).

Publication types

Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Bacterial / blood*
Antibodies, Viral / blood*
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects*
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Drug-Related Side Effects and Adverse Reactions / epidemiology
Drug-Related Side Effects and Adverse Reactions / pathology
Female
Haemophilus Vaccines / administration & dosage
Haemophilus Vaccines / adverse effects*
Haemophilus Vaccines / immunology*
Humans
Infant
Male
Poliovirus Vaccine, Inactivated / administration & dosage
Poliovirus Vaccine, Inactivated / adverse effects*
Poliovirus Vaccine, Inactivated / immunology*
Vaccination / adverse effects*
Vaccination / methods*
Vaccines, Combined / administration & dosage
Vaccines, Combined / adverse effects
Vaccines, Combined / immunology

Substances

Antibodies, Bacterial
Antibodies, Viral
DTP-IPV-Hib vaccine
Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Poliovirus Vaccine, Inactivated
Vaccines, Combined

Associated data

ClinicalTrials.gov/NCT00287092